E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Erosive osteoarthritis of the hand (EHOA) |
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E.1.1.1 | Medical condition in easily understood language |
Erosive arthritis of the finger joints |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019115 |
E.1.2 | Term | Hand osteoarthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the symptoms of erosive hand osteoarthritis. |
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E.2.2 | Secondary objectives of the trial |
Further objectives are to evaluate the effects on pain, disease activity, structural damage, quality of life, safety and tolerability. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Must understand and voluntarily sign an informed consent form including written consent for data protection
- Must be male or female and aged ≥ 18 years at time of consent
- Must have a diagnosis of erosive hand osteoarthritis according to ACR criteria for at least six months
- Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC), proximal and/or distal interphalangeal joints
- Must have active disease at screening and randomization with at least two swollen and tender PIP and/or DIP joints; with the same two joints affected at both screening and randomization.
- Must have a patients self assessment of pain at baseline of at least 40% on a VAS
- Must have negative rheumatoid factor (RF) and anti-CCPantibody
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E.4 | Principal exclusion criteria |
- History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies
- History or Diagnosis of Fibromyalgia
- Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target hand OA joint(s)
- Pregnant or lactating female
- History of active Mycobacterium tuberculosis infection within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated
- Any anti-inflammatory or immunosuppressive therapy for any condition including, but not limited to, glucocorticoids, methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus and azathioprine within 35 days of randomization and throughout the study
- Use of NSAIDs within 35 days of randomization and throughout the study
- Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 84 after treatment start |
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E.5.2 | Secondary end point(s) |
Absolute values and change from baseline as well as proportion of patients in each treatment group who achieve improvements (≥0%, ≥20%, ≥50%) in the following self reporting tests, at day 84 and at day 168 after treatment start compared with Baseline: AUSCAN index, Patients self assessment of pain (VAS), Physicians and Patients self assessment of global status (VAS), HAQ, SACRAH, Duration of joint stiffness, Swollen and tender joint counts, RAMRIS scoring system, SF36, Safety and Tolerability. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 84 and Day 168 after treatment start |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as last patient last visit (protocol section 3.6) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |